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The PREPARE Trial: Exercise Before Surgery to Improve Recovery in Older People With Frailty

StatusUnknown
PhaseNot applicable
Started2020-02-24
View on ClinicalTrials.gov ↗

Amendment history

2026-09-06
Trial status changed: Active, Not Recruiting → Unknown
2024-08-26
Study Status v7
Trial statusActive, Not Recruiting→Unknown
Primary completion dateestimated 2024-06-30→confirmed 2024-06-05
2024-04-02
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v6
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2023-10-25
Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v5
Primary completion date2024-02-02→2024-06-30
Completion date2025-02-02→2025-05-30
Eligibility criteria+146 characters
[...] d 12 weeks from enrollment Exclusion Criteria: Inability to communicate inspeak English or in French UnreachableCo-morbidity preventing assessment or understanding of questionnaires Unable to be contacted by telephone Unwilling to participate in exercise program Cardiac, neurological or orthopedic procedure Palliative surgery Cardiac,Certain neurologicalcardiovascular or orthopedic procedures.conditions
Secondary endpoints12 entries, revised
Function - Timed5 UpTimes andSit Goto TestStand Health System - Discharge positiondisposition
Study description+343 characters
[...] ts: Parallel-arm multicenter randomized controlled trial at 1411 Canadian hospitals. People => 60 years old with frailty (Cl [...] lative risk reduction)) (α=0.025; 2 pair-wise comparisons). Due to surgical delays and cancellations as a result of the COVID-19 pandemic, our trial sample size has seen more participants having surgery outside of their expected time to operation than originally predicted. To account for this, and to ensure adequate power for our analyses, our final sample s [...] Expertise: Our team features multidisciplinary clinical and [...]
Study sitescontacts updated at 1 of 1 site
2023-10-12
Study Status, Study Design v4
Enrollment target750→850
Show 3 earlier versions
2022-11-29
Study Status, Contacts/Locations, IPDSharing v3
Primary completion date2023-07-02→2024-02-02
Completion date2024-07-02→2025-02-02
Study sitescontacts updated at 1 of 1 site
2020-02-25
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-02-02→confirmed 2020-02-24
Study sites0→1
2020-02-03
Study Status v1
Start date2020-01-02→2020-02-02
2020-01-07
Original filing
This study evaluates whether participating in a home-based exercise program leads to lower levels of complication rates and patient-reported disability after surgery. Half of the participants will be randomized into the exercise group, while the other half will be randomized into the control group.
Trial Details
NCT Number NCT04221295
Lead Sponsor Ottawa Hospital Research Institute
Conditions Frailty, Surgery--Complications, Disability Physical
Enrollment 850 participants
Start Date 2020-02-24
Primary Completion 2024-06-05 (estimated)
Study Completion 2025-05-30 (estimated)
Updated on ClinicalTrials.gov 2024-08-27